hai
when can we expect certificates of partcipants, who have cleared exams in april, 2008
dr.r.srinivasa rao
s07praf10094
industrail programme in pharma regulatory affairs
Sunday, August 31, 2008
Friday, August 29, 2008
REGULATORY AFFAIRS: ETERNAL LEARNING
If you talk about regulatory affair ,many budding scientists dodn’t know what regulatory affairs profession is ? The reason behind the lack of awareness among scientists is that collection of advanced regulatory affair programe are not designed keeping in mind the science curriculam.Still the regulatory affair profession is most rich and rewarding career.
According to RAPS(Regulatory affair professional society):The regulatory field is more concerned about making, approving safe and effective healthcare product worldwide.But this indefinite description fails to show the true side of this profession.
Working professionals have similar views considering regulatory careers,though they are working on dissimilar aspect of regulatory affair.In addition regulatory scientist unquestionably believes that knowledge of regulatory rules,policies,laws and strategies requires no formal training.Those who have entered this profession with core science background have a systematic approach and impart their knowledge.
It is never ending process of regulatory learning and the professionals have to keep themselves updated in terms of both current scientific and general regulatory development,the thing which is to be appreciated about this career.Again to excel and to make a mark in regulatory career is to keep yourself,the first to be informed about the latest regulatory developments.The most interesting thing about this profession and career is that professionals can learn more and more about latest development in regulatory sector.
Regulatory affairs department is relatively flexible among those employed in different sectors with science background and the scientific skills needed are similar to their counterparts.Regulatory affairs is the most future secured,highly successful and satisfying career.Professionls employed believes that scientific knowledge,regulatory,communication skills and the desire to know and grow makes this profession a lifetime of learning.
According to RAPS(Regulatory affair professional society):The regulatory field is more concerned about making, approving safe and effective healthcare product worldwide.But this indefinite description fails to show the true side of this profession.
Working professionals have similar views considering regulatory careers,though they are working on dissimilar aspect of regulatory affair.In addition regulatory scientist unquestionably believes that knowledge of regulatory rules,policies,laws and strategies requires no formal training.Those who have entered this profession with core science background have a systematic approach and impart their knowledge.
It is never ending process of regulatory learning and the professionals have to keep themselves updated in terms of both current scientific and general regulatory development,the thing which is to be appreciated about this career.Again to excel and to make a mark in regulatory career is to keep yourself,the first to be informed about the latest regulatory developments.The most interesting thing about this profession and career is that professionals can learn more and more about latest development in regulatory sector.
Regulatory affairs department is relatively flexible among those employed in different sectors with science background and the scientific skills needed are similar to their counterparts.Regulatory affairs is the most future secured,highly successful and satisfying career.Professionls employed believes that scientific knowledge,regulatory,communication skills and the desire to know and grow makes this profession a lifetime of learning.
For Careers In Regulatory Affairs and Current Regulatory Articles,Regularly Go Through The Blog And Last Date Of Application For Industry Programe In Pharma Regulatory Affairs Is 15 SEPTEMBER 2008.
Monday, August 25, 2008
Regulatory Professionals:Pivotal For Pharmaceutical
The Article provides information on how regulatory affair professionals acts as a backbone for pharmaceuticals,biologics,medical device industry. Professionals employed in this sector participate at each level of drug development, clinical trial application,post market surveillance.The procedure includes filling application for the safety and efficacy of a drug which is yet to get market approvals before regulatory authorities like DCA,CDSCO and finally have to get U.S FDA approvals.
Apart from visiting and contacting regulatory authorities for final market approvals.Sometimes they have to contact or coordinate timely with their in house team for timely market approvals,for a drug to make final presence in market. It is the responsibility of regulatory professional to get timely market approvals, somehow if market approvals got delayed,the organization have to bear financial losses.
There are Regulatory experts who provide regulatory advice to pharmaceuticals ,biologics,medical device and food industry to assure compliance with various regulatory authorities.They conduct audit of pharmaceutical manufacturing facilities and their suppliers and check for their compliance with FDA regulation and principles.Further they conduct audit of clinical investigator.They also assist in prepration and review of regulatory submission to FDA including Investigational New Drug Application(INDs),Abbreviated New Drug Application(ANDA),New Drug Application(NDAs) and Clinical Trial Application(CTAs)
Apart from visiting and contacting regulatory authorities for final market approvals.Sometimes they have to contact or coordinate timely with their in house team for timely market approvals,for a drug to make final presence in market. It is the responsibility of regulatory professional to get timely market approvals, somehow if market approvals got delayed,the organization have to bear financial losses.
There are Regulatory experts who provide regulatory advice to pharmaceuticals ,biologics,medical device and food industry to assure compliance with various regulatory authorities.They conduct audit of pharmaceutical manufacturing facilities and their suppliers and check for their compliance with FDA regulation and principles.Further they conduct audit of clinical investigator.They also assist in prepration and review of regulatory submission to FDA including Investigational New Drug Application(INDs),Abbreviated New Drug Application(ANDA),New Drug Application(NDAs) and Clinical Trial Application(CTAs)
Friday, August 22, 2008
Indian Regulatory System:Destination For Global Clinical Trials
Bringing and developing Regulatory Affairs profession in Indian pharma industry is initiative of Indian government in the interest of public health,by controlling and checking the strength,efficacy,purity,safety of pharmaceuticals,veterinary products,cosmetics,so as to deliver a quality product in Indian market.Regulatory Affairs is the one of the most regulated department in pharmaceuticals,biotechnology,medical devices industries and above all in clinical research organization(CROs).
Indian Pharma majors are confronting a stiff competition among themselves and all the major companies are eyeing India as one of the best destination for research and development investments.Again Indian government and various health regulatory bodies playing a pivotal role and taking tremendous steps to showcase India as the best destination for conducting their clinical trials.Since the cost for conducting clinical trials is one-fifth relatively to other countries.
In India there are many hospitals engaged for conducting clinical trials with ICH-GCP trained investigators.Due to the latest advancement in the technology,many MNCs are keen to allow phase-1 clinical trials for the molecules discovered abroad.
MNCs who did not choosen India earlier due to lack of global regulatory guidelnes are now approaching India because India has released it’s guidelines on global clinical trials. India now is a TRIPS compliant and already it had entered into product patent system in 2005.
Necessary action will be taken against those pharma companies which do not comply with schedule M and against counterfeit drug manufacture so they have to face dire consequences like life imprisonment and heavy penalties.
Indian Pharma majors are confronting a stiff competition among themselves and all the major companies are eyeing India as one of the best destination for research and development investments.Again Indian government and various health regulatory bodies playing a pivotal role and taking tremendous steps to showcase India as the best destination for conducting their clinical trials.Since the cost for conducting clinical trials is one-fifth relatively to other countries.
In India there are many hospitals engaged for conducting clinical trials with ICH-GCP trained investigators.Due to the latest advancement in the technology,many MNCs are keen to allow phase-1 clinical trials for the molecules discovered abroad.
MNCs who did not choosen India earlier due to lack of global regulatory guidelnes are now approaching India because India has released it’s guidelines on global clinical trials. India now is a TRIPS compliant and already it had entered into product patent system in 2005.
Necessary action will be taken against those pharma companies which do not comply with schedule M and against counterfeit drug manufacture so they have to face dire consequences like life imprisonment and heavy penalties.
Due to advancement in Indian regulatory system,its rapidly gaining the attention of different countries,as india will be the future destination for global clinical trials.
Wednesday, August 20, 2008
Tuesday, August 19, 2008
BECOME A FREE LANCER REGULATORY AFFAIRS CONSULTANT
Regulatory Affairs is a great and ever increasing career which happened to be in pharmaceutical industry and the profession is most rewarding and lucrative.The profession creates numerous opportunities not only as a regulatory professional in industry but also a freelancer consultant.
Who is a Freelancer regulatory consultant ?
A freelancer regulatory consultant works for national and offshore pharmaceutical company or sometimes they have to work for a short period with their In-house regulatory team.
Freelancer regulatory consultants need to contact medical and regulatory agencies for early approvals and prepare documents showing efficacy and safety of indications as a part of their work
What are the Possibilities for career in future ?
To become a regulatory consultant one should have sound knowledge background and above all should be well versed with the regulatory environment and regulatory skills.One can start his/her career as a regulatory consultant business.
Important skills for someone to become a regulatory consultants ?
One should have critical ability to translate intricate terms and content into more simpler and precise manner which is easier to understand.
Who is a Freelancer regulatory consultant ?
A freelancer regulatory consultant works for national and offshore pharmaceutical company or sometimes they have to work for a short period with their In-house regulatory team.
Freelancer regulatory consultants need to contact medical and regulatory agencies for early approvals and prepare documents showing efficacy and safety of indications as a part of their work
What are the Possibilities for career in future ?
To become a regulatory consultant one should have sound knowledge background and above all should be well versed with the regulatory environment and regulatory skills.One can start his/her career as a regulatory consultant business.
Important skills for someone to become a regulatory consultants ?
One should have critical ability to translate intricate terms and content into more simpler and precise manner which is easier to understand.
One can convince assessors and their clients that you have a right approach and views.
One should have regulatory skills while contacting and meeting healthcare regulatory agencies.
Go for it! Ways of working for Pharmaceuticals varies from industry to industry and Scope of opportunities in this sector are great.
For Careers And Job Oppurtunities In Regulatory Affairs Read More Updates And Relevant News On Blog
Saturday, August 16, 2008
Wednesday, August 13, 2008
Bioinformatics Institute of India, BII organized an Induction Program for “Advance Program in Clinical Trial, Research & data Management” on Sunday, 10th august, 08 at Rai’s Party Lounge, Shopprex Mall, Noida.The Program was attended by BII Director, Program Director, Faculty, administrative member & Students of Clinical Trial Program
The Program started with the presentation of Dr.Kumud Sarin, Program Director of BII. She addressed the students with entire program overview of “Advance Program in Clinical Trial, Research & Data Management” She introduced the students with the various visiting faculty from industry & academia and also interacted with the students very well related to all their queries regarding the Program. Her presentation covered the Basic Program Details, Program curriculum, introduction of various faculties & Clinical Trial introduction.Afterwards, Dr. Neena Valecha, Scientist (E) of Malaria Research Centre ICMR educates the students about various career opportunities that exist in the field of Clinical Trial, Research & Data Management. She also informed the students about various Good Clinical Practices being designed by ICMR.
Another Program faculty, Mr. Asif Khan, an expert in SAS Programming explained the students about Clinical Data Management & Role of IT in Clinical Trials.
Mr.G.K Srivastava, Clinical Trial Coordinator with a leading hospital, is another faculty for the Program. He interacted with students regarding the Clinical Trial Project Management. He discussed the various opportunities & challenges in the area of Clinical Trial Project Management.
Each of the faculty interacted very well with students & explained them about the various opportunities in this growing field of Clinical Trials. The induction program organized by BII was very successful and was appreciated by one and all.
Tuesday, August 12, 2008
Regulatory Affairs Professional In A Outsourcing Buisness
Regulatory Affairs department plays a pivotal role in driving the R&D efforts of the company to the market.It takes a lot of time for a product to make its final presence in the market.And Its the regulatory affairs department which is responsible for getting timely market approvals.Delay in getting market approvals can effect the market share and revenue thus generated. And the only success lies for the pharmaceuticals is timely market approvals from regulators.
So to get the timely approvals,the pharmaceuticals either should have a regulatory departmennt with strong regulatory knowledge or they should get all the approvals outsourced through regulatory consulting firms.
In Today's scenario,with changing global regulatory norms.Outsourcing regulatory work seems to be beneficial and less time consuming rather than making a large regulatory department which is time consuming and is expensive.And the consultants needs to update their knowledge in current regulation, so as to make the approval process less time consuming.
There are many regulatory consulting firms which outsource regulatory work both at large scale and small scale. Outsourcing regulatory work depends upon core competencies which varies from outsorcing firm to firm and on the quality of work provided by a outsourcing firm which in turn depends on the regulatory affairs professionals employed.Regulatory firm hired by the customer company can surely expedite the regulatory approval process if the customer company shows the active participation.
For Career In Regulatory Affairs,Read Daily Updates And Relevant News On Blog
Thursday, August 7, 2008
Regulatory Affairs Profession And Skills Are Coveted
Of all the medical industry professions revealing salary growth and providing strong and quick opportunities, regulatory affairs professionals are doing particularly well than their peers. Among respondents to the MD&DI survey, those in regulatory and legal affairs earning handsome than their counterparts except general and corporate management.A study conducted by RAPS(RAPS; Rockville, MD) reveals that Among other trends, it showed that base salaries for U.S. regulatory professionals rose 9.8% from 2003 to 2006, compared with 7.6% for peers over the same time period. The publicly released portion of the study does not isolate device professionals from those in other FDA-regulated industries, but a RAPS spokesperson says that there is virtually no difference among the industries. Trends over the past 10–12 years, shows tremendous scope of practise.Regulatory Affairs professionals are working not only on multiple product lines, but also that they have greater involvement through the preclinical, clinical and postmarket surveillance stages.Regulatory professionals with knowledge and regulatory skills plays a vital role in organization in designing regulatory strategies,resulting in positive salary trends and the same trend applies to those in the clinical field.Regulatory and clinical professions are in demand and getting numerous lucrative offers. Reason behind this is that the candidates dodn’t change organizations often.Professionals who are well versed in clinical trials and regulatory functions particularly with profiles related to PMA track devices especially implantables are highly desired by MNC organization.Substantial growth has been seen within organization involved with the development of new implantables therapies to treat cardiovascular and neurological disorders
For Careers In Regulatory Affairs, Read Daily Updates And Relevant News On Blog
Tuesday, August 5, 2008
The Dearth Of Regulatory Affairs People In Japan
The Shortage Of Good Regulatory Affairs People In Japan Is A Major Headache For Pharmaceuticals And Medical Devices Firms.
- The work involves a blend of medical expertise and an intimate understanding of Japanese regulation and the vast bureaucracy of the MHLW. A good regulatory affairs executive knows where to take risks, as well as where the regulator will give ground – and where it will not.
- Regulatory affairs professionals tend to enjoy technical challenges, and their job only remains interesting if they are constantly challenged with new products.
- Relationships are of critical importance in Japanese culture; if a regulatory affairs executive lacks relationships at headquarters, it may be difficult for them to speak up or they may start to look outside.
SOURCE:http://www.heidrick.com
Monday, August 4, 2008
Job Search For Regulatory Affairs Professionals Has Got Quicker And Easier
For All Regulatory Affairs Professionals,Follow The Tips And The Job Is Yours.
JOB HUNTING TIPS
Keeping an eye open to opportunities makes a lot of sense in today's business world. Profit/loss, Wall Street and consumer demand all have an impact on today's businesses. And ultimately, that impact plays havoc with people's lives. The Pharmaceutical industry is a segment of the economy where stability is something that is often taken for granted. So, keep an eye open.
Watching the job market in the industry is really a simple task. The best way is to maintain contact with former co-workers and supervisors. A call once every 6 months or so, a card for the holidays or an email can pay off down the road when you might need to contact someone from years past. It is also a way to listen to the pulse of the industry. Everyone receives calls from Head Hunters; sometimes two or 3 a day. Listen closely and keep your resume up to date.
GETTING ACTIVE
Your first task (because you've always kept your resume updated) is to start a "Job Diary". Any time you send out a resume, log it by date, recipient and response. If you decide to work with a recruiter, make absolutely sure that they are not to send out your resume without your express approval for a specific role. You don't want your resume "hanging in the wind". There have been all too many times when we have made contact with a client and made a presentation about a specific candidate, only to find out that the candidate has already been submitted. At that point, the candidate might never have existed, because no company will put themselves in a position where they might be liable for two fees.
RESUMES
If a resume is simply a long list of tasks and accomplishments, the 15 seconds or so that might be spent on an initial review will never have the desired result: an interview. Build your resume from the Top Down; in other words, summarize your career with a few sentences at the top, then explain your roles in the light they deserve. Make sure that your summary tells readers why you are qualified for the role; then show them
JOB HUNTING TIPS
Keeping an eye open to opportunities makes a lot of sense in today's business world. Profit/loss, Wall Street and consumer demand all have an impact on today's businesses. And ultimately, that impact plays havoc with people's lives. The Pharmaceutical industry is a segment of the economy where stability is something that is often taken for granted. So, keep an eye open.
Watching the job market in the industry is really a simple task. The best way is to maintain contact with former co-workers and supervisors. A call once every 6 months or so, a card for the holidays or an email can pay off down the road when you might need to contact someone from years past. It is also a way to listen to the pulse of the industry. Everyone receives calls from Head Hunters; sometimes two or 3 a day. Listen closely and keep your resume up to date.
GETTING ACTIVE
Your first task (because you've always kept your resume updated) is to start a "Job Diary". Any time you send out a resume, log it by date, recipient and response. If you decide to work with a recruiter, make absolutely sure that they are not to send out your resume without your express approval for a specific role. You don't want your resume "hanging in the wind". There have been all too many times when we have made contact with a client and made a presentation about a specific candidate, only to find out that the candidate has already been submitted. At that point, the candidate might never have existed, because no company will put themselves in a position where they might be liable for two fees.
RESUMES
If a resume is simply a long list of tasks and accomplishments, the 15 seconds or so that might be spent on an initial review will never have the desired result: an interview. Build your resume from the Top Down; in other words, summarize your career with a few sentences at the top, then explain your roles in the light they deserve. Make sure that your summary tells readers why you are qualified for the role; then show them
Neuland requires Deputy Manager-Regulatory Affairs (APIs)
About the position : Position reports to Senior Manager-Regulatory Affairs and is based out of the manufacturing location near Hyderabad.
Expected Candidate Profile : Masters in Chemistry or PhD in Chemistry with 5 to 7 years of experience in RA function with API/Bulk Drug manufacturing companies having customers from the regulated markets.
How to apply : Interested persons may please send their resumes to careers@neulandlabs.com.
About Neuland :
Neuland (Laboratories Limited) is a quality conscious and research driven, reliable Active Pharmaceutical Ingredients manufacturing company, specializing in Contract Research and Manufacturing. (In business) since 23 years, Neuland is a preferred source for all the major generic companies across the globe. Neuland, a $50 Million company, having the largest market share of Ciprofloxacin Hcl in US & Europe has close to 25 products across 8 different therapeutic segments in our portfolio.
Neuland's multi-product manufacturing facilities at Bonthapally and Pashamylaram (close to Hyderabad) are inspected and approved by USFDA and both the units also boast GMP approval from TGA, Australia. Neuland has been accredited with COS from EDQM for Eight of its API's across four therapeutic categories. Neuland services more than 800 customers spread across 80 countries.
Neuland with 27 USDMF's and more than 305 DMF filings with various Health Authorities across Europe and other regulated markets is testimony enough to Neuland's unrelenting commitment for being and continuing to be a preferred source worldwide.
Expected Candidate Profile : Masters in Chemistry or PhD in Chemistry with 5 to 7 years of experience in RA function with API/Bulk Drug manufacturing companies having customers from the regulated markets.
How to apply : Interested persons may please send their resumes to careers@neulandlabs.com.
About Neuland :
Neuland (Laboratories Limited) is a quality conscious and research driven, reliable Active Pharmaceutical Ingredients manufacturing company, specializing in Contract Research and Manufacturing. (In business) since 23 years, Neuland is a preferred source for all the major generic companies across the globe. Neuland, a $50 Million company, having the largest market share of Ciprofloxacin Hcl in US & Europe has close to 25 products across 8 different therapeutic segments in our portfolio.
Neuland's multi-product manufacturing facilities at Bonthapally and Pashamylaram (close to Hyderabad) are inspected and approved by USFDA and both the units also boast GMP approval from TGA, Australia. Neuland has been accredited with COS from EDQM for Eight of its API's across four therapeutic categories. Neuland services more than 800 customers spread across 80 countries.
Neuland with 27 USDMF's and more than 305 DMF filings with various Health Authorities across Europe and other regulated markets is testimony enough to Neuland's unrelenting commitment for being and continuing to be a preferred source worldwide.
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